[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Rules and Regulations]
[Pages 48391-48396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22523]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0854; FRL-8429-7]
Meptyldinocap; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes import tolerances for combined
residues of meptyldinocap, 2-(1-methylheptyl)-4,6-dinitrophenyl (2E)-2-
butenoate and 2,4-DNOP, 2,4-dinitro-6-(1-methylheptyl)phenol expressed
as meptyldinocap in or on grape. Dow AgroSciences LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 23, 2009. Objections and
requests for hearings must be received on or before November 23, 2009,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0854. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 308-9354; e-mail address: waller.mary @epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult
[[Page 48392]]
the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0854 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before November 23, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0854, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 13, 2009 (74 FR 16866) (FRL-8396-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E7294) by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN
46268. The petition requested that 40 CFR part 180 be amended by
establishing import tolerances for residues of the fungicide
meptyldinocap, as the parent 2,4-dinitro-6-(1-methylheptyl) phenyl
crotonate and the 2,4-dinitro-6-(1-methylheptyl) phenol metabolite, in
or on grape; grape, juice; and grape, wine at 0.3 parts per million
(ppm). That notice referenced a summary of the petition prepared by Dow
AgroSciences LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
determined that tolerances are not needed for grape, wine and grape,
juice. The reason for these changes is explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
import tolerances for combined residues of meptyldinocap, 2-(1-
methylheptyl)-4, 6-dinitrophenyl (2E)-2-butenoate and 2,4-DNOP, 2,4-
dinitro-6-(1-methylheptyl)phenol expressed as meptyldinocap on grape at
0.20 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Meptyldinocap is one of the six isomers found in the older
fungicide dinocap (dinocap is 22% meptyldinocap and 77% remaining five
isomers). Based on a comparison of the toxicological databases, EPA has
determined that meptyldinocap and dinocap are toxicologically
different, with meptyldinocap being less toxic. Unlike dinocap, which
was teratogenic in mice and rabbits, meptyldinocap caused no
developmental toxicity in any species tested. In addition, a comparison
of subchronic studies in the mouse for dinocap with similar studies for
meptyldinocap indicated that dinocap caused liver toxicity and death
(JMPR 1998), whereas toxicity was absent with meptyldinocap following
treatment for 28 days at a higher dose. Finally, the most sensitive
endpoint for dinocap was ocular effects in the dog. No ocular effects
were evident with meptyldinocap in a subchronic study in dogs which was
extended from 90 days to 1 year specifically to determine if ocular
effects were elicited.
Meptyldinocap caused no deaths following acute oral
(LD50 >2,000 milgrams/kilograms body weight (mg/kg/bw)) or
dermal (LD50 >5,000 (mg/kg bw)) exposures. No abnormal
clinical observations were recorded following dermal exposure other
than erythema/edema at the dose site at 5,000 mg/kg bw beginning on day
1 and persisting through days 4-9. Meptyldinocap is minimally
irritating to the eye and slightly irritating to the skin and exhibited
a skin sensitization potential under the conditions of the local lymph
node assay. Short-term (90-day)
[[Page 48393]]
exposure of rats to meptyldinocap led to decreased body weight, body
weight gain, and food consumption in both sexes at the highest dose
tested (113 mg/kg bw/day). Dogs treated with low doses of meptyldinocap
(approximately 4 mg/kg bw/day) for the same length of time showed
evidence of hepatic toxicity, specifically as significantly increased
ALT (alanine aminotransferase) and AST (aspartate aminotransferase)
levels that were sustained throughout the treatment period. However,
unlike the parent mixture dinocap, there was no evidence of ocular
toxicity in dogs with meptyldinocap during the 90-day treatment period,
or when treatment of these dogs was extended to 1 year. No adverse
effects were observed in mice treated with meptyldinocap for 28 days.
Meptyldinocap was tested in a number of developmental toxicity studies
in several species. Unlike dinocap, which was teratogenic in mice and
rabbits, meptyldinocap caused no developmental toxicity in any species
tested. Meptyldinocap was negative in two in vitro mutagenicity
studies, as well as in one in vivo and one in vitro clastogenicity
assay.
Long-term toxicity studies in rodents, including carcinogenicity
studies, and studies designed to assess male and female fertility were
not performed with meptyldinocap. However, the hazard database for
meptyldinocap, in conjunction with the dinocap hazard database, is
adequate for the purposes of this action on imported grapes.
Specific information on the studies received and the nature of the
adverse effects caused by meptyldinocap as well as the no-observed-
adverse-effect-level and the lowest-observed-adverse-effect-level from
the toxicity studies can be found at http://www.regulations.gov in
document Meptyldinocap (DE-126/Dinocap II): PP#7E7294. Tolerances on
Fresh and Processed Imported Grapes. Human-Health Risk Assessment at
pp. 22-35 in docket ID number EPA-HQ-OPP-2008-0854.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for meptyldinocap can be
found at http://www.regulations.gov in document Meptyldinocap (DE-126/
DinocappII): PP# 7E7294. Tolerances on Fresh and Process Imported
Grapes. Human-Health Risk Assessment at pp. 11 in docket ID number EPA-
HQ-OPP-2008-0854.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to meptyldinocap, EPA considered exposure under the
petitioned-for tolerances as well as all existing dinocap tolerances in
(40 CFR 180.341). EPA assessed dietary exposures from meptyldinocap in
food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
meptyldinocap; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the (USDA) 1994-1996
and 1998 (CSFII). As to residue levels in food, EPA assumed tolerance
level residues and 100 percent crop treated (PCT) for all potential
sources of meptyldinocap from the proposed use on imported grapes and
meptyldinocap exposure from use of dinocap on imported apples and
grapes. Since 22% of technical dinocap is meptyldinocap and since the
proportion of meptyldinocap in dinocap residues is unknown, the chronic
analysis assumed that 100% of the dinocap residues on imported apples
and grapes were meptyldinocap. Based on dinocap processing studies, the
default grape juice and wine processing factors were reduced to 1. For
raisin, apple juice, and dried apple, default processing factors were
retained. Anticipated residue and/or PCT were not used.
iii. Cancer. The carcinogenic potential of meptyldinocap has not
been tested. However, the parent mixture dinocap was previously
classified as ``Group E, Evidence of non-carcinogenicity in humans.''
The Agency concluded that given the lack of developmental, ocular, and
genetic toxicities with meptyldinocap, dinocap toxicity represents a
``worst case'' scenario relative to meptyldinocap. Therefore, the
Agency concluded an exposure assessment was not necessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for meptyldinocap. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. There is no expectation
that meptyldinocap residues would occur in surface water or ground
water sources of drinking water. Meptyldinocap is proposed for use only
on imported grapes, and established tolerances for dinocap are for
imported grapes and apples only. The sole exposure route for the U.S.
population is via food exposure. There are no registered uses of
meptyldinocap or dinocap in the United States.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Neither meptyldinocap nor dinocap are registered for any specific
use patterns that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity.
[[Page 48394]]
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found meptyldinocap to share a common mechanism of
toxicity with any other substances, and meptyldinocap does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
meptyldinocap does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act of 1996 (FQPA) safety factor (SF). In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility of offspring following prenatal exposure of
mice, rats, or rabbits. In both the rat and rabbit developmental
toxicity studies, toxicity to offspring was not observed, whereas
maternal toxicity was observed at the highest dose tested in both
studies. In the non-guideline developmental toxicity studies in the
mouse, meptyldinocap failed to cause either offspring or maternal
toxicity in either study. One of these studies also assessed postnatal
toxicity to offspring. No evidence of postnatal toxicity was observed.
These results contrast with those for dinocap, which was used as a
positive control in the study and caused developmental toxicity as well
as adverse postnatal effects.
3. Conclusion. EPA has determined that an FQPA SF of 3X is
necessary to protect the safety of infants and children given that the
POD for estimating chronic human risk was chosen from a subchronic
study. Use of a 3X SF, in the form of an uncertainty factor for
subchronic-to-chronic extrapolation, with the NOAEL of 1.5 mg/kg bw/day
from the 90-day toxicity study in dogs yields an effective NOAEL of 0.5
mg/kg bw/day for meptyldinocap. EPA concludes that reliable data
support this FQPA SF based upon the following considerations:
i. The adjusted NOAEL for meptyldinocap is virtually identical to
the NOAEL used for the (cRfD) for dinocap (0.4 mg/kg bw/day). Use of a
larger SF for meptyldinocap would yield a lower point of departure than
that for dinocap, which would be inappropriate, given that
meptyldinocap is a significantly less toxic chemical than dinocap.
Evidence showing the lower toxicity of meptyldinocap include:
Meptyldinocap is one of six isomers contained in dinocap.
Toxicological studies have isolated the teratogenic isomer in dinocap,
and it is not meptyldinocap.
Meptyldinocap is considered less toxic than dinocap based on the
lack of developmental and ocular toxicities with meptyldinocap at
approximately 5X the doses contained in dinocap.
A comparison of subchronic studies in the mouse for dinocap with
similar studies for meptyldinocap indicated that dinocap caused liver
toxicity and death (JMPR 1998), whereas toxicity was absent with
meptyldinocap following treatment for 28 days at a higher dose.
Unlike dinocap, there is no evidence of offspring susceptibility
with meptyldinocap in any of four developmental toxicity studies across
three species tested. Unlike dinocap, there was no evidence of
neurotoxicity or neuropathology in any of the submitted studies for
meptyldinocap.
Unlike dinocap, there was no effect of treatment on mortality,
clinical signs, ophthalmological examinations, or select gross or
microscopic pathology in dogs treated for 1 year with meptyldinocap.
The dinocap cRfD was based on a chronic study in dogs.
ii. Evidence from the meptyldinocap dog study indicates that
extending exposure from subchronic to chronic would not have produced a
lower NOAEL. As indicated above, the extension of the meptyldinocap dog
study for an additional 9 months did not result in effects on
mortality, clinical signs, ophthalmological examinations, or select
gross or microscopic pathology as it did with dinocap. Moreover, while
levels of serum hepatic enzymes in dogs in the meptyldinocap study were
increased significantly over controls throughout the 90-day exposure
period, the serum hepatic enzyme levels did not become more severe over
time.
iii. Although EPA does not have toxicology studies conducted with
meptyldinocap to fulfill all data requirements, EPA concludes that
between the dinocap and meptyldinocap studies it has a complete
database. The dinocap database was incomplete due to a lack of a
developmental neurotoxicity study but such a study is not needed for
meptyldinocap because there was no evidence of neurotoxicity or
neuropathology in any of the submitted studies for meptyldinocap. These
results contrast with those of dinocap in which minor neuropathology
was noted in dogs treated with dinocap as a positive control for 90
days. EPA began requiring acute and subchronic neurotoxicity testing of
all food and non-food use pesticides on December 26, 2007. Since this
requirement went into effect after the tolerance petition was
submitted, these studies are not yet available for meptyldinocap. In
the absence of specific neurotoxicity studies, EPA has evaluated the
available toxicity data to determine whether an additional database
uncertainty factor is needed to account for potential neurotoxicity.
Given the lack of neurotoxicity or neuropathology in any meptyldinocap
studies, EPA does not believe that conducting acute or subchronic
neurotoxicity testing will result in a NOAEL less than 1.5 mg/kg/day
already established for the cRfD for meptyldinocap, and an additional
uncertainty factor is not needed to account for the lack of these data.
Immunotoxicity testing is also required as a result of changes made to
the pesticide data requirements in December of 2007. An immunotoxicity
study has not been conducted with meptyldinocap. However, an in vivo
immunotoxicity study with additional in vitro measurements (Smialowicz,
et al., 1992) has been conducted with dinocap in mice and published in
the open literature. Immune function, cellularity, organ weights, and
histopathology were measured over several doses in the study.
Immunotoxicity was observed at a thirtyfold higher dose than the
effective NOAEL used to calculate the cRfD for meptyldinocap. Because a
well conducted immunotoxicity study with dinocap was performed
previously, and
[[Page 48395]]
since meptyldinocap is considered less toxic than dinocap, the
requirement for an immunotoxicity study with meptyldinocap has been
satisfied by the literature study with dinocap.
iv. There is no evidence of offspring susceptibility with
meptyldinocap in any of four developmental toxicity studies across
three species tested.
v. There are no residual uncertainties identified in the exposure
database for meptyldinocap. The dietary food exposure assessments were
performed based on 100 PCT and tolerance-level residues as well as a
very conservative assumption of what meptyldinocap exposure could occur
from use of dinocap. No exposure to meptyldinocap in drinking water or
from residential use is expected because neither meptyldinocap or
dinocap is registered for use in the United States. The exposure
assessment will not underestimate the exposure and risks posed by
meptyldinocap.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
meptyldinocap is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
meptyldinocap from food will utilize 35% of the cPAD for (children 1 to
2 years old) the population group receiving the greatest exposure.
There are no proposed or existing residential uses of meptyldinocap,
and exposure through drinking water is not expected. Therefore, dietary
risk represents the aggregate risk and does not exceed the Agency's
LOC.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Meptyldinocap is not registered for any use patterns that would
result in residential exposure and exposure through drinking water is
not expected. Therefore, the short-term aggregate risk is the sum of
the risk from exposure to meptyldinocap in food which does not exceed
the Agency's LOC.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Meptyldinocap is not registered for any use patterns that would
result in intermediate-term residential exposure and exposure through
drinking water is not expected. Therefore, the intermediate-term
aggregate risk is the sum of the risk from exposure to meptyldinocap in
food which does not exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. Based on structural
similarities and the demonstrated lower toxicity of meptyldinocap as
compared to dinocap, the cancer classification of Group E--Evidence of
non-carcinogenicity in humans for dinocap was extended to
meptyldinocap.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to meptyldinocap residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no currently established Codex, Canadian, or Mexican
maximum residue limits for meptyldinocap on grapes. Therefore,
harmonization is not an issue.
C. Revisions to Petitioned-For Tolerances
The Agency is not establishing tolerances on grape juice and wine
because dinocap grape processing studies indicated that residues are
reduced in juice and wine (0.15X). The Agency believes that due to
structural similarities, dinocap and meptydinocap will partition in a
similar manner during processing. Therefore, separate grape juice and
wine tolerances are unnecessary.
V. Conclusion
Therefore, tolerances are established for combined residues of
meptyldinocap, 2-(1-methylheptyl)-4,6-dinitrophenyl (2E)-2-butenoate
and 2,4-DNOP, 2,4-dinitro-6-(1-methylheptyl)phenol expressed as
meptyldinocap in or on grapes at 0.20 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the
[[Page 48396]]
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
As such, the Agency has determined that this action will not have a
substantial direct effect on States or tribal governments, on the
relationship between the national government and the States or tribal
governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian tribes. Thus, the Agency has determined that Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000) do not apply to this final
rule. In addition, this final rule does not impose any enforceable duty
or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 9, 2009.
Steven Bradbury,
Acting Director, Office of Pesticides Program.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321 (q), 346a and 371.
0
2. Section 180.648 is added to subpart C to read as follows:
Sec. 180.648 Meptyldinocap; tolerances for residues.
(a) General. Tolerances are established for the combined residues
of the fungicide meptyldinocap, 2-(1-methylheptyl)-4,6-dinitrophenyl
(2E)-2-butenoate and 2,4-DNOP, 2,4-dinitro-6-(1-methylheptyl)phenol
expressed as meptyldinocap in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts Per Million
------------------------------------------------------------------------
Grape 0.20
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E9-22523 Filed 9-22-09; 8:45 am]
BILLING CODE 6560-50-S